Active Ingredient And Purpose
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Dolodent Liquid
FDA Label NDC 55758-505
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Dolodent (NDC 55758-505). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient and purpose, otc - purpose, uses, warnings, do not use, stop use and ask your doctor or dentist if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Active ingredient Purpose
Benzocaine 20%..............................Oral pain reliever
Uses
For the temporary relief of
- canker sores
- minor injury of the mouth and gums
- minor irritation of the mouth and gums caused by dentures or orthodontic appliances
Warnings
Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
- pale, gray, or blue colored skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy
Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetics.
Flammable. Keep away from fire or flame. Avoid smoking during application.
Do Not Use
- more than directed
- for more than 7 days unless directed by a dentist or doctor
- for teething
- in children under 2 years of age
Stop Use And Ask Your Doctor Or Dentist If
- sore mouth symptoms do not improve in 7 days
- irritation, pain or redness persists or worsens
- swelling, rash or fever develops
Keep Out Of Reach Of Children.
If more than used for pain is accidentally swallowed or an allergic reaction occurs, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 2 years of age and older:
- apply product to a cotton swab or finger to the affected area. Allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a dentist or doctor
- children under 12 years of age a should be supervised in the use of the product
- children under 2 years of age: do not use
Other Information
- do not use if clear seal over cap is torn, broken, or missing
- store between 68-77°F (20-25°C)
Inactive Ingredients
alcohol, clove oil, glycerin, polyethylene glycol, propylene glycol, sodium saccharin, sodium methylparaben
Questions Or Comments?
+1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com
Dist. By/ Por:
Dist. by/ por:
PHARMADEL LLC
New Castle, DE 19720
+1-866-359-3478
www.pharmadel.com
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